Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorMSD Italia S.r.l.
About this trial
This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
Patients who received allogeneic HSCT between January 2018 and June 2020;
Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent & Privacy Form (ICF), if applicable.
Disqualifiers
Letermovir use at any time
Trial population
About 230 patients from birth to less than 18 years of age allogeneic HSCT recipients at risk of developing CMV infection and/or disease who underwent allogeneic HSCT between January 2018 and June 2020 in the participating hospitals will be enrolled in the study. The selected hospitals will be the main ones in Italy based on the number of transplants performed every year and also considering the geographical distribution.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Summary of demographic and baseline characteristics
Description through frequencies and percentages (for categorical variables) and mean and median values, SD, quartiles, interquartile ranges and extreme values (for continuous variables).
Time frame
at baseline (day of transplant)2
CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT
Proportion of patients CMV R+ at transplantation. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Time frame
at baseline (day of transplant)3
CMV serostatus
R+/D-, R+/D+ and R-/D+ combination frequencies. CMV-seroprevalence and serostatus will be described according to the recipient or donor positivity. Comparisons will be conducted using the Chi-square or Fisher's exact test (for categorical variables), or the t-test or Wilcoxon rank sum test (for continuous variables).
Time frame
at baseline (day of transplant)4
Donor type
Allogeneic HSCT characteristics
Time frame
at baseline (day of transplant)Secondary outcomes
1
Rate of clinically significant CMV infection
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame
at day +100, day +200 and during the first year post allogeneic HCT2
Median time to first CS-CMVi
A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame
during the first year after transplantation3
Rate of viral infections other than CMV
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame
at day +100, day +200 and during the first year post allogeneic HCT4
Rate of bacterial infections
Incidence rates will be computed by dividing the number of events by the total number of person-years and then multiplying per 100. A Kaplan-Meier curve will describe the timing of first CS-CMVi and mortality.
Time frame
at day +100, day +200 and during the first year post allogeneic HCTSponsors and contacts
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Source ClinicalTrials.gov